Director of Quality Assurance

JOB DESCRIPTION

Our client is currently seeking a driven and ambitious Director of Quality Assurance to join their team. This is a unique opportunity for a highly motivated professional who has a go-getter attitude.

1) Adhere to company's Standard Operating Procedures (SOPs) and Safety Protocols, FDA Regulations for Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) and devices2) Develop and maintain an understanding of company's products and general biological and chemical systems utilized within the department3) Prepare external audits and client & government regulatory inspections and serve as the primary representative4) Oversee vendor audits and participate in internal audits in those areas of the quality system that the director is not directly responsible for5) Respond to audit and inspection findings and prepare summaries for management and associated department review6) Evaluate the training needs of QA/QC employees and oversee QA/QC training and competency evaluations7) Maintain documented competency on analytical instrumentation and methods used for testing and inspecting medical devices8) Designate qualified employees as trainers and serve as the default trainer for the QA/QC Department9) Analyze Quality Inspection reports, monitor and review process controls10) Gather and analyze statistical data, perform trend analyses, participate in root cause investigations, and identify targets for corrective action, preventive action and training11) Oversee QA/QC portion of and participate in, CAPA, Complaint, Non-conformance, and Engineering and Document change control processes and investigations12) Oversee the development and maintenance of Document Control and Record Control systems that meet FDA, AATB and ISO standards and regulations company-wide13) Oversee the completion and retention of documentation pertaining to SOPs14) Write and revise a variety of technical documents including SOPs, quality standards and specifications, training documents and inspection and testing protocols as needed and assigned15) Participate in the completion of Device History Records or Donor Processing Records as applicable

CRITICAL REQUIREMENTS

1) University degree is required (preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply)2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)3) Recent experience in the biotechnology industry is strongly preferred4) Preference will be given to people have recent experience in quality assurance

If you imagine yourself working for an excellent company whose employees believe in team work and making great contributions to the industry, this could be a golden opportunity for you.